NCT07732907Recruiting
Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
This study will evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by John Cunningham virus (JCV), among people with multiple sclerosis who have been treated with ozanimod. The study will collect and review reported cases of PML to describe patient characteristics and estimate how often PML occurs among people treated with ozanimod. Researchers will assess factors that may be associated with the occurrence of PML, such as age, duration of ozanimod exposure, prior immunosuppressant use, lymphopenia, and JCV antibody status .
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 15 (estimated)
- First submitted
- 24 Jul 2026
- Start date
- 4 Jun 2026
- Primary completion date
- 31 Jul 2041
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Multiple sclerosis
- NCT number
- NCT07732907
What you commit to
- Study type: Observational
- Planned participants: 15
- From 4 Jun 2026 to the primary completion date, 31 Jul 2041
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- There are no additional exclusion criteria.
Who the study is looking for
- Adverse event (AE) report with MedDRA Preferred Term of " John Cunningham virus (JCV) cerebrospinal fluid test positive", " JCV granule cell neuronopathy", or "Progressive multifocal leukoencephalopathy (PML)" reported to the Sponsor between 4-Jun-2026 and 31-Jul-2041.
- AE report(s) originating from spontaneous post-marketing reports, post-marketing observational studies with primary data collection, or patient support programs.
- Diagnosis of multiple sclerosis before the initial AE report.
- Exposure to at least one dose of ozanimod before onset of PML symptoms.
- PML event assessed as "definite" or "probable" by the adjudication committee.
- PML assessed as "related" to ozanimod by the adjudication committee.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bristol Myers Squibb Coordinator of this site? Confirm its status | Lawrenceville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.